Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Pfizer1,083 enrolled

Overview

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,083

Conditions

Endometrial Hyperplasia Osteoporosis

Interventions

Bazedoxifene/Conjugated EstrogenDRUG

Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Bazedoxifene/Conjugated EstrogenDRUG

Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

CE 0.45 mg/MPA 1.5mgDRUG

Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Generally healthy, postmenopausal women, aged 40 to less than 65 years * Intact uterus * At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL. Exclusion Criteria: * Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy) * A history or active presence of clinically important medical disease * Malabsorption disorders

Locations (9)

Pfizer Investigational Site

Upland, California, United States

Pfizer Investigational Site

Inverness, Florida, United States

Pfizer Investigational Site

West Palm Beach, Florida, United States

Pfizer Investigational Site

Outcomes

Primary Outcomes

Percentage of Participants With Hyperplasia at Screening

Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.

Time frame: Screening

Percentage of Participants With Hyperplasia at Month 12

Time frame: Month 12

Bone Mineral Density (BMD) of Lumbar Spine at Screening

BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

Time frame: Screening

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12

BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

Data from ClinicalTrials.gov

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Secondary Outcomes

Percentage of Days With Breast Pain

Percentage of days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.

Time frame: Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52

Percentage of Participants With Uterine Bleeding or Spotting

Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.

Time frame: Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52

Percentage of Participants With Hyperplasia at Month 24

Time frame: Month 24

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24

BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

Time frame: Baseline, Month 24

Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24

BMD measurements of the total hip were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

Time frame: Baseline, Month 24